Avails Medical Submits Equant™ System For Fda 510(K) Clearance
Tuesday, June 13, 2023
Avails Medical, a pioneering company in rapid and automated antibiotic susceptibility testing (AST) solutions, has announced the submission of its eQUANTTM system to the FDA for 510(k) clearance. This innovative system aims to provide standardized inoculum directly from positive blood cultures, facilitating faster turnaround times in routine AST procedures by up to one day. The emergence of antibiotic-resistant bacteria and the global concern over antimicrobial resistance make rapid diagnostics a crucial aspect of addressing this challenge.
Dr. Niaz Banaei, Professor of Pathology and Medicine and Medical Director at Stanford Health Care Clinical Microbiology Laboratory, expressed the potential of the eQUANT system to enable physicians to shift from costly broad-spectrum antibiotics to more effective and cost-efficient therapies. The eQUANT system boasts unique features such as a compact size, user-friendly interface, and affordable economics, making it suitable for widespread adoption. In a pilot study conducted at renowned clinical laboratories, the eQUANT system demonstrated over 98% correlation with the subculture gold standard.
Dr. Knopfmacher, CEO of Avails Medical, expressed excitement about reaching the milestone of FDA submission for the eQUANT system. This step brings the company closer to commercializing the system not only in the United States but also in other countries. The eQUANT system is designed to seamlessly integrate into the workflow of clinical laboratories, potentially accelerating AST procedures. Avails Medical will showcase the eQUANT System, as well as the eASTTM System, at the upcoming ASM conference in Houston.
In addition to the FDA submission, Avails Medical announced securing $5.4 million in non-dilutive funding from CARB-X for its rapid eAST system. This funding, obtained after achieving additional gating milestones, is provided by CARB-X, a global non-profit partnership focused on combatting antibiotic-resistant bacteria by supporting the development of new antibiotics, vaccines, diagnostics, and other essential products.